Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated … (NCT07093593) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs
260 participantsStarted 2025-09-01
Plain-language summary
Solid cancers are frequently treated with chemotherapies that target the DNA of cancer cells. It has recently come to light that bacteria are also the target of chemotherapies used in oncology. The results of current studies demonstrate the close link between the composition of the microbiota, the immune system, toxicity and the efficacy or otherwise of anti-cancer treatments.
In this context, the study will measure the influence of treatment with anticancer molecules known to activate the bacterial SOS response on the emergence of antibiotic-resistant commensal bacteria in the gut microbiota of cancer patients. Furthermore, this study will investigate the existence of a close link between changes in the intestinal microbiota determined by the induction or non-induction of the SOS response, bacterial translocation, the integrity of the intestinal barrier and the antitumor immune response.
The RAMA trial plans to collect stool and blood samples from two different cohorts of patients:
* Unexposed cohort: patients receiving anti-cancer treatment that does not induce bacterial SOS response.
* Exposed cohort: patients receiving anti-cancer treatment inducing the bacterial SOS response.
Patients' stools will be collected within 7 days of their first chemotherapy treatment and within 7 days of the 3rd chemotherapy cycle. Two blood samples will be taken at the same time as the stool samples.
The results obtained from this prospective clinical research will then be investigated in two experimental laboratory models.
The aim is to demonstrate that cytotoxic anticancer drugs promote the emergence of antibiotic-resistant commensal bacteria, by means of this large-scale study comprising a clinical component, which is the subject of the research presented in this protocol, combined with laboratory research components.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Squamous cell carcinoma of the upper aerodigestive tract (Non-metastatic, locally advanced, operable or not; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))
. Cervical and endometrial cancer (ocally advanced, Non-metastatic; Patients receiving concomitant radiochemotherapy using a platinum salt (cisplatin, carboplatin))
. Gynecological cancer (advanced stage ; Patient to receive platinum salt + paclitaxel chemotherapy)
. Mammary carcinoma (localised; Patient to receive adjuvant or neoadjuvant chemotherapy with epirubicin and cyclophosphamide without other associated treatment (targeted therapy / immunotherapy))
. Urothelial carcinoma (all stage ; Patient to receive neoadjuvant or adjuvant chemotherapy with platinum salt and gemcitabine)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine whether the digestive microbiota of patients exposed to SOS-inducing cytotoxic cancer drugs favors the emergence of antibiotic-resistant commensal bacteria compared to patients exposed to other non-SOS-inducing cytotoxic cancer drugs.